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A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626885
First Posted: June 25, 2012
Last Update Posted: January 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
  Purpose
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with receiving multiple drugs schizophrenia.

Condition Intervention Phase
Schizophrenia Drug: MP-214 Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 60 weeks ]

Enrollment: 42
Study Start Date: May 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MP-214 Drug: MP-214
Patients who meet eligibility criteria will be administered a once daily oral low dose of MP-214 for four weeks, then flexible dose of MP-214

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent obtained from the patient before the initiation of any study-specific procedures
  • Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
  • Patients who receive 1 or more antipsychotic drugs
  • Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

  • Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626885


Locations
Japan
Kurayoshi, Tottori, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
  More Information

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01626885     History of Changes
Other Study ID Numbers: A002-A8
First Submitted: June 19, 2012
First Posted: June 25, 2012
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Schizophrenia
Antipsychotic Agents
Mental Disorder
Psychotropic Drugs
Dopamine Agents
Central Nervous System Agents

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders